A drug that has been used to treat nerve gas and other types of pesticide and chemical poisoning in children off label for years is now approved for pediatric use, the Food and Drug Administration announced.
The drug, pralidoxime chloride, available as Protopam Chloride in the United States, was approved in 1964, as a treatment for poisoning caused by organophosphate pesticides and chemicals, such as nerve agents, in adults.
It is now available in an intramuscular formulation in addition to the previously available intravenous formulation. Protopam Chloride, manufactured by Baxter Healthcare Corp., works by acting as an antidote “by slowing the attachment of the chemical to nerve endings,” according to the FDA statement announcing the approval.
Because the drug is now approved for pediatric use, the label will include dosing information in children, which will provide health care professionals with information on “how to use this drug safely and effectively,” Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said.
Using intravenous drugs in children, especially in emergency situations, can be difficult, so “having the new option of intramuscular injection might help health care professionals use this medicine quickly and accurately,” Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics, pointed out in the statement.
Blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure are among the adverse reactions associated with the drug in adults and children, according to the FDA.
Symptoms associated with poisoning with organophosphate pesticides or chemicals can range from mild symptoms, such as a runny nose or vomiting, to serious symptoms that include difficulty breathing, weakness, and convulsions, according to the FDA statement.